First human dose-escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2 (SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus

Table 1 Summary of adverse events

		Remogliflozin etabonate dose
	Placebo	20 mg	50 mg	150 mg	500 mg	1000 mg	Total
Healthy Subjects	n = 10	n = 8	n = 8	n = 8	n = 8	n = 8	n = 10
	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
At least one adverse event	4 (40)	2 (25)	3 (38)	1 (13)	3 (38)	1 (13)	8 (80)
Adverse events reported by >1 subject in total
Headache	1 (10)	1 (13)	1 (13)	0	2 (25)	1 (13)	4 (40)
Blood creatine phosphokinase increased	1 (10)	0	0	0	1 (13)	0	2 (20)
Drug-related adverse events
Headache	1 (10)	1 (13)	1 (13)	0	0	1 (13)	3 (30)
Dizziness	0	0	0	0	0	1 (13)	1 (10)
Diarrhea	0	1 (13)	0	0	0	0	1 (10)
Hot flush	0	0	0	0	0	1 (13)	1 (10)
T2DM subjects	n = 6		n = 6		n = 6		n = 6
T2DM subjects	n (%)		n (%)		n (%)		n (%)
At least one adverse event	3 (50)		1 (17)		2 (33)		4 (67)
Adverse events reported by >1 subject in total
Muscle cramp	1 (17)		1 (17)		0		2 (33)
β₂-microglobulin increased	0		0		2 (33)		2 (33)
Drug-related adverse events
Nausea	0		0		1 (17)		1 (17)
β₂-microglobulin increased	0		0		1 (17)		1 (17)
Pain in extremity	0		0		1 (17)		1 (17)

ISSN: 2050-6511